Clinical Policy: Dutasteride (Avodart) Reference Number: ERX.NPA.26 Effective Date: 09.01.17 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Dutasteride (Avodart®) is 5 alpha-reductase inhibitor.

FDA approved indication Avodart is indicated:  For the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery  In combination with the alpha-adrenergic antagonist, tamsulosin, for the treatment of symptomatic BPH in men with an enlarged prostate

Limitation of use: Avodart is not approved for the prevention of prostate cancer.

Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Avodart is medically necessary when the following criteria are met:

I. Initial Approval Criteria A. Benign Prostatic Hyperplasia: 1. Diagnosis of BPH; 2. Age ≥ 18 years; 3. Member is contraindicated or has experienced clinically significant adverse effects to excipients in generic dutasteride; 4. Failure of 1 other PDL medication indicated for BPH (e.g., doxazosin, finasteride, prazosin, tamsulosin, terazosin) at up to maximally indicated doses unless all are contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 0.5 mg per day (1 capsule per day); Approval duration: 12 months

B. Other diagnoses/indications 1. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized)

II. Continued Therapy A. Benign Prostatic Hyperplasia (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 0.5 mg per day (1 capsule per day). Approval duration: 12 months

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B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized)

III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy – ERX.PA.01 or evidence of coverage documents

IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BPH: benign prostatic hyperplasia FDA: Food and Drug Administration PDL: preferred drug list

Appendix B: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose Doxazosin (Cardura) 1 capsule once daily 8 mg/day Finasteride (Proscar) 5 mg once daily 5 mg/day Prazosin (Minipress) 2 mg twice daily 9 mg/day Tamsulosin (Flomax) 0.4 mg once daily 0.8 mg/day Terazosin (Hytrin) 5 – 10 mg once daily 20 mg/day

V. Dosage and Administration Indication Dosing Regimen Maximum Dose BPH 0.5 mg once daily 0.5 mg/day

VI. Product Availability Capsules: 0.5 mg

VII. References 1. Avodart Drug Monograph. Clinical Pharmacology. Accessed June 2017. http://www.clinicalpharmacology-ip.com 2. Avodart Prescribing Information. Somerset, NJ: GlaxoSmithKline; April 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf. Accessed June 23, 2017. 3. McVary KT, Roehrborn CG et al. American Urological Association guideline: management of benign prostatic hyperplasia (BPH). Published 2010; reviewed and validity confirmed 2014. Available at: https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(2010-reviewed-and- validity-confirmed-2014)#x2513. Accessed June 2017.

Reviews, Revisions, and Approvals Date P&T Approval Date Policy split from ERX.NSMN.12 Benign prostatic hyperplasia 06/17 08/17 agents and converted to new template. Removed criteria of If request is for non-PDL brand agent, failure of 2 PDL brand agents, unless contraindicated. Replaced failure of generic dutasteride with contraindication/intolerance to excipients in dutasteride because a member failing dutasteride should not receive the same medication (Avodart).

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Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information.

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members.

This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions.

©2017 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein.

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